Unidos Contra el VPH

Official title

Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border

Overview

The purpose of the Unidos Contra el VPH study is to help find options to screen, or check, for cervical cancer that individuals can do at home to help prevent and detect cervical cancer early. Usually, people get screened for cervical cancer with a Pap smear and human papillomavirus (HPV) test by a health care provider. This is not always easy for individuals who are not able to get to a clinic or feel uncomfortable having the procedure done. That is why we want to find other ways that may be easier and more comfortable for people to be screened for cervical cancer. The two main questions the study aims to answer are: 1. How do the following three cervical cancer screening methods compare for improving screening completion rates? o In-home HPV self-sampling with a vaginal swab * In-home HPV self-sampling with urine testing * In-clinic traditional Pap smear with HPV test 2. What are participant beliefs and preferences regarding these three screening methods? Participants in the study will be randomly assigned to one of three groups. This means each person has an equal chance of being placed in any group. They will also complete two surveys as part of the study. The three screening method groups are described below: Group 1: Urine Self-Sampling * Participants in this group will receive a kit with a urine sample cup to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the urine sample to the lab. Group 2: Vaginal Swab Self-Sampling o Participants in this group will receive a kit with a vaginal swab and collection tube to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the sample to the lab. Group 3: In-Clinic Screening * An in-clinic co-testing appointment is scheduled for a Pap smear and HPV test done together at Project Vida Health Center. By comparing these approaches, this study aims to improve access to cervical cancer screening and provide better options for those who face barriers to clinic-based screening.

Interventions

• Device Self-sampling with urine
  Urine is self-collected at home using a urine sample cup.
• Device Self-sampling with swab
  A vaginal cell sample is self-collected at home using a swab and collection tube.
• Device In-clinic Pap/HPV co-testing
  Cervico-vaginal cell samples are collected by a clinician during a Pap smear/HPV co-test appointment.

Primary outcome measures

• Comparison of Completion Rates Among Three Cervical Cancer Screening Methods [Time frame: Screening completion within 60 days of enrollment]

Secondary outcome measures (1)

• Comparison of Participant Beliefs and Preferences for HPV Self-Collection Versus Clinician-Collected Samples [Time frame: Participants will complete surveys at two time points: baseline (at enrollment) and follow-up (within 2 weeks of screening completion).]

Eligibility criteria

Inclusion criteria

• Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.

Exclusion criteria

• Having had a hysterectomy or a personal history of cervical cancer.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• Project Vida Health Center — El Paso

Identifiers

NCT: NCT06825689 · CPRIT-RP240208 · STUDY00005986

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗